Skip to content
AMR Drug RepurposingSmart Screeningresearch prototype

Tirbanibulin

FDA-approved product (ointment, topical), marketed as Klisyri.

Registered studies
20
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

Chemical structure of Tirbanibulin
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Actinic keratosis

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Other chemotherapeutics
FDA pharmacologic class
Microtubule Inhibitor FDA label ↗
Anti-infective classification
Classified as another kind of anti-infective (for example an antifungal, antiviral or antiparasitic medicine).WHO ATC D06BX03

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis and MRSA. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA51.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli35.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae19.9% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis43.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

20registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Open Tirbanibulin in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-8.4 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.3 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.8 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.3 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Tirbanibulin with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead

    NCT07273656 · start 2026-11-30

    Registered record
    Registry ID
    NCT07273656
    Conditions
    Keratosis; Actinic Keratoses
    Interventions
    Cryotherapy + Tirbanibulin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Not yet recruiting
    Start
    2026-11-30
    Completion
    2028-11-30
    Enrolment
    59

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionKeratosis; Actinic Keratoses
    InterventionCryotherapy + Tirbanibulin
    PhasePhase 3
    Registry statusNot yet recruiting

  • Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)

    NCT07657988 · start 2026-04-02

    Registered record
    Registry ID
    NCT07657988
    Conditions
    Actinic Keratosis (AK)
    Interventions
    Tirbanibulin
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2026-04-02
    Completion
    2026-10
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionActinic Keratosis (AK)
    InterventionTirbanibulin
    PhaseNot recorded
    Registry statusRecruiting

  • Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment

    NCT07010692 · start 2025-05-16

    Registered record
    Registry ID
    NCT07010692
    Conditions
    Keratinocyte Carcinoma; Basal Cell Carcinomas; Squamous Cell Carcinoma; Skin Cancer
    Interventions
    Tirbanibulin ointment 1%; non-ablative fractional laser
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2025-05-16
    Completion
    2030-06
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionKeratinocyte Carcinoma; Basal Cell Carcinomas; Squamous Cell Carcinoma; Skin Cancer
    InterventionTirbanibulin ointment 1%; non-ablative fractional laser
    PhasePhase 1 / Phase 2
    Registry statusRecruiting

  • Tirbanibulin for Pediatric Warts

    NCT06791525 · start 2025-05-01

    Registered record
    Registry ID
    NCT06791525
    Conditions
    Warts Hand
    Interventions
    Tirbanibulin ointment 1%
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2025-05-01
    Completion
    2026-12-30
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionWarts Hand
    InterventionTirbanibulin ointment 1%
    PhasePhase 4
    Registry statusRecruiting

  • Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

    NCT06648447 · start 2024-10-22

    Registered record
    Registry ID
    NCT06648447
    Conditions
    Actinic Keratosis (AK)
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2024-10-22
    Completion
    2025-10-31
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionActinic Keratosis (AK)
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting

  • Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

    NCT06112522 · start 2024-02-16

    Registered record
    Registry ID
    NCT06112522
    Conditions
    Cell Carcinoma
    Interventions
    Tirbanibulin
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-02-16
    Completion
    2027-12-16
    Enrolment
    50

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCell Carcinoma
    InterventionTirbanibulin
    PhasePhase 2
    Registry statusRecruiting

  • A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

    NCT06135415 · start 2023-12-21

    Registered record
    Registry ID
    NCT06135415
    Conditions
    Keratosis, Actinic
    Interventions
    Tirbanibulin; Vehicle ointment
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2023-12-21
    Completion
    2025-11-25
    Enrolment
    280

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionKeratosis, Actinic
    InterventionTirbanibulin; Vehicle ointment
    PhasePhase 3
    Registry statusCompleted

  • Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

    NCT06026358 · start 2023-10

    Registered record
    Registry ID
    NCT06026358
    Conditions
    Actinic Keratoses
    Interventions
    Tirbanibulin
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2023-10
    Completion
    2024-12
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionActinic Keratoses
    InterventionTirbanibulin
    PhasePhase 4
    Registry statusWithdrawn

  • Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

    NCT05900258 · start 2023-05-11

    Registered record
    Registry ID
    NCT05900258
    Conditions
    Actinic Keratosis
    Interventions
    Tirbanibulin
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-05-11
    Completion
    2023-11-13
    Enrolment
    22

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionActinic Keratosis
    InterventionTirbanibulin
    PhasePhase 4
    Registry statusCompleted

  • Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults

    NCT05713760 · start 2023-04-17

    Registered record
    Registry ID
    NCT05713760
    Conditions
    Superficial Basal Cell Carcinoma
    Interventions
    Tirbanibulin Ointment 1%
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2023-04-17
    Completion
    2024-03-07
    Enrolment
    5

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSuperficial Basal Cell Carcinoma
    InterventionTirbanibulin Ointment 1%
    PhasePhase 2
    Registry statusCompleted

  • A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses

    NCT05741294 · start 2023-01-20

    Registered record
    Registry ID
    NCT05741294
    Conditions
    Actinic Keratosis
    Interventions
    Tirbanibulin 2.5 mg ointment
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-01-20
    Completion
    2024-01-19
    Enrolment
    334

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionActinic Keratosis
    InterventionTirbanibulin 2.5 mg ointment
    PhasePhase 4
    Registry statusCompleted

  • A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

    NCT05387525 · start 2022-10-24

    Registered record
    Registry ID
    NCT05387525
    Conditions
    Keratosis, Actinic
    Interventions
    Tirbanibulin (Klisyri®) 10 mg/g ointment; Diclofenac Sodium 3% Gel
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Active not recruiting
    Start
    2022-10-24
    Completion
    2027-07
    Enrolment
    447

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionKeratosis, Actinic
    InterventionTirbanibulin (Klisyri®) 10 mg/g ointment; Diclofenac Sodium 3% Gel
    PhasePhase 4
    Registry statusActive not recruiting

  • A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

    NCT05279131 · start 2022-06-28

    Registered record
    Registry ID
    NCT05279131
    Conditions
    Keratosis, Actinic
    Interventions
    Tirbanibulin ointment 1%
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2022-06-28
    Completion
    2022-12-28
    Enrolment
    105

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionKeratosis, Actinic
    InterventionTirbanibulin ointment 1%
    PhasePhase 3
    Registry statusCompleted

  • Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis

    NCT05260073 · start 2022-03-09

    Registered record
    Registry ID
    NCT05260073
    Conditions
    Keratosis, Actinic
    Interventions
    Tirbanibulin
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-03-09
    Completion
    2023-03-07
    Enrolment
    300

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionKeratosis, Actinic
    InterventionTirbanibulin
    PhaseNot recorded
    Registry statusCompleted

  • KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis

    NCT05522816 · start 2015-10-27

    Registered record
    Registry ID
    NCT05522816
    Conditions
    Psoriasis
    Interventions
    KX01 0.01% (0.1 mg/g); Placebo; KX01 0.1% (1.0 mg/g); KX01 1% (10 mg/g) for 5 days; KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-10-27
    Completion
    2021-03-10
    Enrolment
    28

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPsoriasis
    InterventionKX01 0.01% (0.1 mg/g); Placebo; KX01 0.1% (1.0 mg/g); KX01 1% (10 mg/g) for 5 days +1 more
    PhasePhase 1
    Registry statusCompleted